| Device Classification Name |
electrode, needle, diagnostic electromyograph
|
|---|
| 510(K) Number |
K120342 |
|---|
| Model |
RLSP393
|
| Device Name |
EMG RECORDING ELECTRODE ASSEMBLY |
|---|
| Applicant |
| RHYTHMLINK INTERNATIONAL, LLC |
| 1140 first st. south |
|
columbia,
SC
29209
|
|
| Contact |
james mewborne |
| Regulation Number | 890.1385
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 02/03/2012 |
|---|
| Decision Date | 06/22/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Neurology
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
